Advanced CancerCEOLENCT01545921
Cancer End Of Life Evaluation
A study testing Quality Of Life questionnaires completion in people with Advanced Cancer, run by Institut Cancerologie de l'Ouest at 10 sites in France.
Trial summary
The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Quality Of Life questionnaires completion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 10 sitesFrance
- Study dates
- 11 Nov 2011to 6 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Palliative advanced cancer patient (Palliative chemotherapy, analgesic radiotherapy, surgery of comfort accepted).
- All cancer locations and cancer type
- Patient having the knowledge of their palliative disease stage.
- Patient follow-up at least once a month by a palliative caregiver.
- Age > or = 18 years.
- Dated and signed consent.
- PS > or = 2
- Life expectation > or = 1 month.
Who cannot join
- Psychiatric Disease or cognitive disorders disrupting the trial understanding and the enlightened and voluntary consent character.
- Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU
Angers, 49933
ICO Paul Papin
Angers, 49933
CHU Minjoz
Besançon, 25030
Institut Bergonié
Bordeaux, 33076
Centre Hospitalier
Cholet, 49325
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.
Read the detailed description
French clinical research in palliative care is confronted with a lack of tools allowing to estimate in a standardized way a patient related outcome. Scales used today are not specifically adapted to quality of life (QoL) at the end of life patient evaluation. So all the relative dimensions to this disease stage are not estimated. What establishes a brake in the improvement of a quality support.
The dimensions of pain, psychological distress, fatigue, decrease of the autonomy are essential points estimated in "classic" questionnaires and frequently used at the palliative disease stage. However the end of life also recovers the domains of the spirituality, oneself's completion, relationship. These elements are essential to dread better QoL at end of life, but are not or do not little approach on the French questionnaires.
The Missoula-Vitas Quality Of Life Index is a questionnaire developed by Byock, Merriman and Kinzbrunner and specifically designed for palliative situations [I. Byock, 1998]. This QoL tool provides an exhaustive assessment of important dimensions in this setting. The short version is composed of 15 items and asks patients to evaluate 5 dimensions: symptoms, function, interpersonal relationships, well-being and transcendence [I. Byock, 1998].
Another tool, the QUAL-E, is longer with 25 items concerning 5 domains: life completion, relations with the health care system, preparation for end of life, symptom severity and affective social support [KE. Steinhauser, 2002]. However, these QoL tools have not been translated and adapted to French. Another concern is that the lack of specificity for cancer patients.
The first step to improve evaluation of how French patients feel about this phase of their disease is to translate these specific end of life QoL tools. Assessing QoL at the end of life with dedicated tools could help to compare therapeutic strategies and could result in improvements in palliative care.
- Conditions
- Advanced Cancer
- Being tested
- Quality Of Life questionnaires completion
- Keywords
- Quality Of Life, Cancer, End of life, palliative setting
- Medical subject headings
- Neoplasms, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Of Life questionnaires completionOther
Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Patients will complete QoL questionnaires in the following order :
MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death Receives: Other: Quality Of Life questionnaires completion |
| Arm B | Experimental | Patients will complete QoL questionnaires in the following order :
QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death Receives: Other: Quality Of Life questionnaires completion |
| Arm C | Experimental | Patients will complete QoL questionnaires in the following order :
MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month and spontaneous QoL completion, until death Receives: Other: Quality Of Life questionnaires completion |
| Arm D | Experimental | Patients will complete QoL questionnaires in the following order :
QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month and spontaneous QoL completion, until death. Receives: Other: Quality Of Life questionnaires completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
Both QUALE and MVQOLI have many questions, and each question is evaluated by a number of points. At the end of completion, a score is calculated thanks to number of points and is used to compare the different times completion :
- no change of score between the 2 first completion (reproductibility)
- change score with baseline
- correlation with QLQ-C15 PAL Score
- correlation with clinical measure (PS, PPS)
Measured: Up to 3 years
Secondary outcomes (3)
Change in Quality of Life at different times
Every month or more, QUALE, MVQOLI and QLQ-C15-PAL will be completed by patient, a final score will be calculated and compared at different times.
Measured: Up to 3 years
Number of spontaneous questionnaire completions
In arms C and D, patients can complete QLQ-C15-PAL and MVQOLI questionnaires at home if they need it. The number of spontaneous questionnaires completions will be evaluated and the impact on quality of life assessed thanks to calculated score.
Measured: Up to 3 years
Rate of completion
Every month or more, the 3 questionnaires QUALE, MVQOLI and QLQ-C15-PAL have to be completed by patient. The rate of completion will be calculated.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study start11 Nov 2011
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Why it stopped: End of inclusions without reaching the expected number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Commer, MD, Principal investigator, Institut Cancerologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545921
- Sponsor's protocol ID
- CPP-435
- Other IDs
- 2010-A00196-33
- Acronym
- CEOLE
- Status last verified
- Nov 2020
- First submitted
- 16 Mar 2011
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Poirier AL, Kwiatkowski F, Commer JM, D'Aillieres B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.
PubMed 22520742
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
- ClinicalTrials.gov ID
- NCT01545921
- Acronym / sponsor ID
- CEOLE / CPP-435
- Conditions
- Advanced Cancer
- Keywords
- Quality Of Life, Cancer, End of life, palliative setting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of inclusions without reaching the expected number of patients
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 11 Nov 2011 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.
Detailed description
French clinical research in palliative care is confronted with a lack of tools allowing to estimate in a standardized way a patient related outcome. Scales used today are not specifically adapted to quality of life (QoL) at the end of life patient evaluation. So all the relative dimensions to this disease stage are not estimated. What establishes a brake in the improvement of a quality support.
The dimensions of pain, psychological distress, fatigue, decrease of the autonomy are essential points estimated in "classic" questionnaires and frequently used at the palliative disease stage. However the end of life also recovers the domains of the spirituality, oneself's completion, relationship. These elements are essential to dread better QoL at end of life, but are not or do not little approach on the French questionnaires.
The Missoula-Vitas Quality Of Life Index is a questionnaire developed by Byock, Merriman and Kinzbrunner and specifically designed for palliative situations [I. Byock, 1998]. This QoL tool provides an exhaustive assessment of important dimensions in this setting. The short version is composed of 15 items and asks patients to evaluate 5 dimensions: symptoms, function, interpersonal relationships, well-being and transcendence [I. Byock, 1998].
Another tool, the QUAL-E, is longer with 25 items concerning 5 domains: life completion, relations with the health care system, preparation for end of life, symptom severity and affective social support [KE. Steinhauser, 2002]. However, these QoL tools have not been translated and adapted to French. Another concern is that the lack of specificity for cancer patients.
The first step to improve evaluation of how French patients feel about this phase of their disease is to translate these specific end of life QoL tools. Assessing QoL at the end of life with dedicated tools could help to compare therapeutic strategies and could result in improvements in palliative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Quality Of Life questionnaires completionPatients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death |
| Arm B | Experimental | Other: Quality Of Life questionnaires completionPatients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death |
| Arm C | Experimental | Other: Quality Of Life questionnaires completionPatients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month and spontaneous QoL completion, until death |
| Arm D | Experimental | Other: Quality Of Life questionnaires completionPatients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month and spontaneous QoL completion, until death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Palliative advanced cancer patient (Palliative chemotherapy, analgesic radiotherapy, surgery of comfort accepted).
- All cancer locations and cancer type
- Patient having the knowledge of their palliative disease stage.
- Patient follow-up at least once a month by a palliative caregiver.
- Age > or = 18 years.
Key exclusion criteria (2 listed)
- Psychiatric Disease or cognitive disorders disrupting the trial understanding and the enlightened and voluntary consent character.
- Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Of Life questionnaires completionBefore randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E. MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D. | Other | Arm A, Arm B, Arm C, Arm D |
Primary outcome
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
Time frame: Up to 3 years
Both QUALE and MVQOLI have many questions, and each question is evaluated by a number of points. At the end of completion, a score is calculated thanks to number of points and is used to compare the different times completion : * no change of score between the 2 first completion (reproductibility) * change score with baseline * correlation with QLQ-C15 PAL Score * correlation with clinical measure (PS, PPS)
3 secondary outcomes
Change in Quality of Life at different times
Time frame: Up to 3 years
Number of spontaneous questionnaire completions
Time frame: Up to 3 years
Rate of completion
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: End of inclusions without reaching the expected number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 22520742Poirier AL, Kwiatkowski F, Commer JM, D'Aillieres B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Commer, MD principal investigator
Institut Cancerologie de l'Ouest
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Of Life questionnaires completion in people with Advanced Cancer, run by Institut Cancerologie de l'Ouest at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of inclusions without reaching the expected number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.